The Oral Microbiota is Associated With Autoimmune Thyroiditis

• ClinicalTrials.gov Identifier: NCT03447093
• Recruitment Status: Unknown
• First Posted: February 27, 2018
• Last Update Posted: February 27, 2018
• Sponsor: First Affiliated Hospital of Harbin Medical University
• Information provided by (Responsible Party): First Affiliated Hospital of Harbin Medical University

Study Description

Brief Summary:

Autoimmune thyroiditis (AITD) mainly includes Hashimoto's thyroiditis (HT) and Grave's disease (GD). Studies have shown that autoimmune thyroiditis is closely related to microbial disorders such as autoimmune thyroiditis However, there is no report on the relationship between oral microecology and autoimmune thyroiditis. Therefore, our group will study the correlation between oral microbiota and AITD.

Condition or disease	Intervention/treatment
Microbiota	Drug: Methimazole Pill; Drug: Propylthiouracil Pill

Detailed Description:

Autoimmune thyroiditis (AITD) mainly includes Hashimoto's thyroiditis (HT) and Grave's disease (GD). Studies have shown that autoimmune thyroiditis is closely related to microbiological disorders. Intestinal microelements Both ecology and oral microecology belong to the category of microorganisms. It has been reported in the literature that intestinal microecology occurs disorder of autoimmune thyroiditis. However, there is no report on the correlation between oral microecology and autoimmune thyroiditis. When oral microbe flora When the immune system is disrupted, the immune balance is broken, the immune system is over-active, and the autoimmune disease (AID) is lost to the autoantigens and non-pathogenic commensal microbial flora antigens, including rheumatoid arthritis, Sjogren's syndrome, systemic lupus erythematosus, inflammatory bowel disease, and allergic diseases. However, the association between oral microbial flora and AITD remains unclear. . Therefore, the research group will carry out the correlation between oral microbial flora and AITD.

Study Design

• Study Type: Observational
• Estimated Enrollment: 120 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: The Oral Microbiota in Autoimmune Thyroiditis is Distinctive And Predictive
• Actual Study Start Date: December 23, 2017
• Estimated Primary Completion Date: December 2019
• Estimated Study Completion Date: December 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
Control group; 30 healthy volunteers were included in the healthy control group
Drug treatment group; 30 GD patients who received treatment with Methimazole Pill or propylthiouracil pill	Drug: Methimazole Pill; Patients who developed GD received methimazole treatment; Drug: Propylthiouracil Pill; Patients who developed GD received propylthiouracil treatment
Incipient group; 30 untreated GD patients
Hashimoto's thyroiditis group; 30 HT patients

Outcome Measures

Primary Outcome Measures :

1. Transcriptional changes in oral microbiota [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months ]
   The microbiota measured by 16S rRNA gene

Secondary Outcome Measures :

1. Serum thyroid function changed [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months ]
   Serum thyroid function measured by Immunohistochemistry

Other Outcome Measures:

1. Serum thyroid related antibodies changed [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months ]
   Serum thyroid related antibodies measured by Immunohistochemistry

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

All patients were included according to the inclusion and exclusion criteria

Criteria

Inclusion Criteria:

• Aged 18 to 65 years
• GD was clinical diagnosed and thyroid function returned to normal
• HT was clinical diagnosed and thyroid function is normal.

Exclusion Criteria:

• Pregnancy
• Lactation
• Cigarette smoking
• Alcohol addiction
• Hypertension
• Diabetes mellitus
• Lipid dysregulation
• BMI > 27
• Recent (< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or Chinese herbal medicine
• History of disease with an autoimmune component, such as MS, rheumatoid arthritis, IBS, or IBD
• History of malignancy or any gastrointestinal tract surgery

Contacts and Locations

Contacts

Contact: Yunwei Wei; +86-0451-85553099; hydwyw11@hotmail.com

Locations

China, Heilongjiang

First affiliated hospital of Harbin medical university; Recruiting

Harbin, Heilongjiang, China, 150001

Contact: Yunwei Wei +86-0451-85553099 hydwyw11@hotmail.com

Sponsors and Collaborators

First Affiliated Hospital of Harbin Medical University

Investigators

• Study Director: Yunwei Wei; First Affiliated Hospital of Harbin Medical University

More Information

Publications:

Qin J, Li R, Raes J, Arumugam M, Burgdorf KS, Manichanh C, Nielsen T, Pons N, Levenez F, Yamada T, Mende DR, Li J, Xu J, Li S, Li D, Cao J, Wang B, Liang H, Zheng H, Xie Y, Tap J, Lepage P, Bertalan M, Batto JM, Hansen T, Le Paslier D, Linneberg A, Nielsen HB, Pelletier E, Renault P, Sicheritz-Ponten T, Turner K, Zhu H, Yu C, Li S, Jian M, Zhou Y, Li Y, Zhang X, Li S, Qin N, Yang H, Wang J, Brunak S, Doré J, Guarner F, Kristiansen K, Pedersen O, Parkhill J, Weissenbach J; MetaHIT Consortium, Bork P, Ehrlich SD, Wang J. A human gut microbial gene catalogue established by metagenomic sequencing. Nature. 2010 Mar 4;464(7285):59-65. doi: 10.1038/nature08821.

Dewhirst FE, Chen T, Izard J, Paster BJ, Tanner AC, Yu WH, Lakshmanan A, Wade WG. The human oral microbiome. J Bacteriol. 2010 Oct;192(19):5002-17. doi: 10.1128/JB.00542-10. Epub 2010 Jul 23.

Kabouridis PS, Pachnis V. Emerging roles of gut microbiota and the immune system in the development of the enteric nervous system. J Clin Invest. 2015 Mar 2;125(3):956-64. doi: 10.1172/JCI76308. Epub 2015 Mar 2. Review.

• Responsible Party: First Affiliated Hospital of Harbin Medical University
• ClinicalTrials.gov Identifier: NCT03447093
• Other Study ID Numbers: Yunwei Wei 2017 -12-23
• First Posted: February 27, 2018
• Last Update Posted: February 27, 2018
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by First Affiliated Hospital of Harbin Medical University:

oral microbiota; 16S rRNA gene; Graves' disease; Methimazole; Propylthiouracil; Hashimoto's thyroiditis

Additional relevant MeSH terms:

Thyroiditis; Thyroiditis, Autoimmune; Hashimoto Disease; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Methimazole; Propylthiouracil; Antithyroid Agents; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antimetabolites; Molecular Mechanisms of Pharmacological Action